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ZENSOR

INTELESENS LIMITED · Model PN1287 · UDI-DI 05060484630082

MHX Prescription

510(k) clearances

33,126

Adverse events (1,928 deaths)

294

Recalls

118

Facilities

Description

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

Recalls

Date	Firm	Reason
2026-09-16	Philips North America	Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity t
2026-09-08	Nihon Kohden America LLC	Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.